SPI ELEMENTRecalls & reported problems across all models
Thommen Medical AG · 28 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1,995
- Deaths reported
- 0
- Injuries reported
- 1,995
- Recalls
- 0
We found 28 models of SPI ELEMENT by Thommen Medical AG in the FDA's device registry (GUDID). Together they are named in 1,995 adverse event reports in the FDA's MAUDE database, received between Feb 1, 2018 and Sep 28, 2026 — classified as 1,995 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (1,495 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported SPI ELEMENT problems
Device problems
- Failure to Osseointegrate1,495
- Loss of Osseointegration480
- Break17
- Loosening of Implant Not Related to Bone-Ingrowth2
- Appropriate Device Problem Term/Code Not Available1
- Loose or Intermittent Connection1
- Unstable1
Patient problems
- Inadequate Osseointegration1,430
- No Code Available551
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available9
- Failure of Implant2
- Implant Pain2
SPI ELEMENT models
28 models, most reported first. Each model has its own page with its reports, recalls and device details.
- SPI ELEMENT 4.13.914Implant, Endosseous, Root-Form232 reports
- SPI ELEMENT 4.13.941Implant, Endosseous, Root-Form194 reports
- SPI ELEMENT 4.13.904Implant, Endosseous, Root-Form179 reports
- SPI ELEMENT 4.13.924Implant, Endosseous, Root-Form176 reports
- SPI ELEMENT 4.13.901Implant, Endosseous, Root-Form172 reports
- SPI ELEMENT 4.13.940Implant, Endosseous, Root-Form152 reports
- SPI ELEMENT 4.13.910Implant, Endosseous, Root-Form139 reports
- SPI ELEMENT 4.13.911Implant, Endosseous, Root-Form115 reports
- SPI ELEMENT 4.13.942Implant, Endosseous, Root-Form106 reports
- SPI ELEMENT 4.13.900Implant, Endosseous, Root-Form83 reports
- SPI ELEMENT 4.13.902Implant, Endosseous, Root-Form82 reports
- SPI ELEMENT 4.13.906Implant, Endosseous, Root-Form64 reports
- SPI ELEMENT 4.13.905Implant, Endosseous, Root-Form61 reports
- SPI ELEMENT 4.13.934Implant, Endosseous, Root-Form47 reports
- SPI ELEMENT 4.13.951Implant, Endosseous, Root-Form41 reports
- SPI ELEMENT 4.13.950Implant, Endosseous, Root-Form36 reports
- SPI ELEMENT 4.13.912Implant, Endosseous, Root-Form35 reports
- SPI ELEMENT 4.13.907Implant, Endosseous, Root-Form20 reports
- SPI ELEMENT 4.13.908Implant, Endosseous, Root-Form10 reports
- SPI ELEMENT 4.13.921Implant, Endosseous, Root-Form10 reports
- SPI ELEMENT 4.13.944Implant, Endosseous, Root-Form9 reports
- SPI ELEMENT 4.13.943Implant, Endosseous, Root-Form8 reports
- SPI ELEMENT 4.13.952Implant, Endosseous, Root-Form8 reports
- SPI ELEMENT 4.13.920Implant, Endosseous, Root-Form7 reports
- SPI ELEMENT 4.13.903Implant, Endosseous, Root-Form4 reports
- SPI ELEMENT 4.13.922Implant, Endosseous, Root-Form3 reports
- SPI ELEMENT 4.13.913Implant, Endosseous, Root-Form1 report
- SPI ELEMENT 4.13.931Implant, Endosseous, Root-Form1 report
Recent SPI ELEMENT adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, bone resorption, peri-implantitis, pain, swelling, abscess.
Patient problems: Inadequate Osseointegration
MAUDE report 50913105 ↗InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, pain, mobility.
Patient problems: Inadequate Osseointegration
MAUDE report 50911095 ↗InjurySep 28, 2026Loss of Osseointegration
Loss of osseointegration, implant achieved osseointegration, primary stability was achieved, implant was completely covered with bone, thread tap used, smoker, peri-implantitis, swelling.
Patient problems: Inadequate Osseointegration
MAUDE report 50911085 ↗InjuryAug 11, 2026Loss of Osseointegration
Loss of osseointegration, primary stability was achieved, implant was completely covered with bone, no thread tap used, inadequate bone quality/quantity.
Patient problems: Inadequate Osseointegration
MAUDE report 50208082 ↗InjuryJul 6, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WASN'T COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, INADEQUATE BONE QUALITY/QUANTITY, INFECTION, INCREASED SENSITIVITY, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25715039 ↗InjuryJun 15, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, SMOKER, PAIN, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 25503427 ↗InjuryMay 26, 2026Failure to Osseointegrate
PRIMARY STABILITY NOT ACHIEVED, NO THREAD TAP USED.
Patient problems: Inadequate Osseointegration
MAUDE report 25276525 ↗InjuryMay 19, 2026Loss of Osseointegration
InjuryMay 19, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration
MAUDE report 25214774 ↗InjuryApr 13, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PAIN.
Patient problems: Inadequate Osseointegration
MAUDE report 24856738 ↗InjuryApr 13, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE, PERI-IMPLANTITIS, MOBILITY (B)(6) ARE SAME PATIENT).
Patient problems: Inadequate Osseointegration
MAUDE report 24855196 ↗InjuryApr 7, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, PAIN, SWELLING, INFLAMMATION, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24800832 ↗InjuryApr 7, 2026Failure to Osseointegrate
IMPLANT DIDN'T ACHIEVE OSSEOINTEGRATION, FISTULA, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24800698 ↗InjuryMar 25, 2026Loss of Osseointegration
InjuryMar 23, 2026Loss of Osseointegration
LOSS OF OSSEOINTEGRATION, IMPLANT ACHIEVED OSSEOINTEGRATION, PRIMARY STABILITY WAS ACHIEVED, IMPLANT WAS COMPLETELY COVERED WITH BONE, NO THREAD TAP USED, PERIODONTAL DISEASE, BONE RESORPTION, PERI-IMPLANTITIS, MOBILITY.
Patient problems: Inadequate Osseointegration
MAUDE report 24660709 ↗
Other Thommen Medical AG products
All Thommen Medical AG devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page